Back to resultsRealtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
Primary Purpose
Atrial Fibrillation
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apple Watch
Sponsored by
About this trial
This is an interventional diagnostic trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria: Had a 10-second 12-lead ECG done at Mayo Clinic Have a high AI-ECG risk score indicating a high likelihood of previously unrecognized AF Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3 Exclusion Criteria: Diagnosed atrial fibrillation Diagnosed dementia Diagnosed end-stage kidney disease History of intracranial bleeding Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder Missing date of birth Residence outside of the U.S. or missing address information
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Apple Watch Intervention Group
Control Group
Arm Description
Participants will be asked to wear an Apple Watch and use the Mayo Clinic ECG Study App to collect and share data with the study team.
Participants will receive usual care.
Outcomes
Primary Outcome Measures
Atrial fibrillation
Number of participants diagnosed with atrial fibrillation
Secondary Outcome Measures
Change in individuals' maximum learning span
Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses the Stricker Learning Span (SLS), which is a computer adaptive word-list memory test that matches test difficulty to user performance. Maximum learning span is total number of words recognized.
Change in processing speed measure
Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses a symbols test to measure processing speed reported in average completion time (seconds).
Ischemic stroke or systemic embolism events
Number of ischemic stroke or systemic embolism events
Major bleeding
Number of major bleeding events
Mortality
Number of participant deaths
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05923359
Brief Title
Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
Official Title
Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this research is to test whether Apple Watch, used as a long-term monitoring device, can enable early detection of atrial fibrillation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Apple Watch Intervention Group
Arm Type
Experimental
Arm Description
Participants will be asked to wear an Apple Watch and use the Mayo Clinic ECG Study App to collect and share data with the study team.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Participants will receive usual care.
Intervention Type
Other
Intervention Name(s)
Apple Watch
Intervention Description
Apple Watch
Primary Outcome Measure Information:
Title
Atrial fibrillation
Description
Number of participants diagnosed with atrial fibrillation
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Change in individuals' maximum learning span
Description
Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses the Stricker Learning Span (SLS), which is a computer adaptive word-list memory test that matches test difficulty to user performance. Maximum learning span is total number of words recognized.
Time Frame
Baseline, 2 years
Title
Change in processing speed measure
Description
Measured using the Mayo Test Drive (MTD):Test Development through Rapid Iteration, Validation and Expansion. A web-based platform for remote self-administered cognitive assessment that uses a symbols test to measure processing speed reported in average completion time (seconds).
Time Frame
Baseline, 2 years
Title
Ischemic stroke or systemic embolism events
Description
Number of ischemic stroke or systemic embolism events
Time Frame
2 years
Title
Major bleeding
Description
Number of major bleeding events
Time Frame
2 years
Title
Mortality
Description
Number of participant deaths
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Had a 10-second 12-lead ECG done at Mayo Clinic
Have a high AI-ECG risk score indicating a high likelihood of previously unrecognized AF
Men with CHA2DS2-VASc2 ≥2 or women with CHA2DS2-VASc ≥ 3
Exclusion Criteria:
Diagnosed atrial fibrillation
Diagnosed dementia
Diagnosed end-stage kidney disease
History of intracranial bleeding
Have an implantable cardiac monitoring device, including a pacemaker, a defibrillator, or implanted loop recorder
Missing date of birth
Residence outside of the U.S. or missing address information
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiaoxi Yao, PhD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials
Learn more about this trial
Realtime Diagnosis From Electrocardiogram Artificial Intelligence-Guided Screening for Atrial Fibrillation With Long Follow-Up (REGAL)
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